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Shalina Healthcare
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Officer - Quality Assurance

Officer - Quality Assurance

Shalina Healthcare

5 years

0 Lacs

pune maharashtra india

Posted:2 days ago| Platform:

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Skills Required

manufacturing monitoring compliance documentation frequency sampling erp transactions inspection reconciliation sap communication coordination drive

Work Mode

On-site

Job Type

Full Time

Job Description

What you become a part of:
The IPQA Officer/Executive will be responsible for ensuring in-process quality assurance activities across all manufacturing operations. The role involves monitoring compliance with SOPs, GMP standards, and regulatory requirements, along with reviewing documentation and supporting process validation.What to expect:

Monitor raw material dispensing activity.

Perform daily IPQA activities as per SOP-defined frequency and ensure timely closure of IPQA observations.

Conduct validation sampling as per approved validation protocols.

Review BMR (Batch Manufacturing Record) and BPR (Batch Packing Record) for accuracy and compliance.

Perform ERP-related transactions of IPQA.

Check BSR (Batch Summary Record) and Shipper inspection as per SOP.

Manage issuance, review, and reconciliation of formats across all departments.

Conduct IPQA rounds and share observations with concerned HODs for corrective action and compliance.

Ensure cleaning, sanitation, and hygiene in all departments to maintain GMP compliance at all times.

Perform sampling of In-process, Semi-Finished Goods (SFG), and Finished Goods (FG) as per procedure.

Key Skills & Competencies:

Strong knowledge of IPQA processes, cGMP, and regulatory guidelines.
Attention to detail with strong documentation and review skills.
Proficiency in ERP systems (preferably SAP or equivalent).
Good communication and coordination skills to work with cross-functional teams.
Ability to conduct inspections, identify deviations, and drive compliance.

Qualifications & Experience:

B.Pharm / M.Pharm / M.Sc. in relevant discipline.
2–5 years of experience in IPQA or Quality Assurance within the pharmaceutical industry.

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Officer - Quality Assurance